While the U.S. Food and Drug Administration (FDA) is obviously supportive of the most expedient means to find a vaccine for COVID-19, new guidance for industry puts some parameters on the agency’s regulatory elasticity.
“Vaccines licensed in the United States must meet the statutory and regulatory requirements for vaccine development and approval, including for quality, development, manufacture, and control [and the] vaccine product must be adequately characterized and its manufacture in compliance with applicable standards including current good manufacturing practice (cGMP),” FDA says. It is critical that vaccine production processes for each vaccine are well defined and appropriately controlled to ensure consistency in manufacturing, the agency adds.
“COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology, to the extent legally and scientifically permissible,” FDA says. Similarly, with appropriate justification, some aspects of manufacture and control may be based on the vaccine platform, and in some instances, reduce the need for product-specific data.
In addition, FDA says any vaccine it ultimately approves will have to demonstrate it is at least 50% more effective than a placebo. By contrast, flu vaccine efficacy has swung from 10% to 60% from 2004 to 2018, according to Centers for Disease Control and Prevention statistics.
Edited by Michael Causey